Tava Wire-Driver
FDA 510(k) K935367 · Tava Surgical Instruments
510(k) numberK935367
Submission
- Device name
- Tava Wire-Driver
- Applicant
- Tava Surgical Instruments
Simi Valley, CA, US - Received
- November 4, 1993
- Decision date
- April 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991588 | EMS Swiss OrthoclastHSZ · Traditional | (Ems Sa) Electro Medical Systems | 07/21/1999SE |
| K972860 | Curvtek TSR SystemHSZ · Traditional | Biolectron, Inc. | 10/31/1997SE |
| K970345 | Alignment InstrumentHSZ · Traditional | Richard Wolf Medical Instruments Corp. | 04/29/1997SE |
| K955084 | Aspach 65,000 (Modification)HSZ · Traditional | The Anspach Effort, Inc. | 01/17/1996SE |
| K954080 | Sodem High Speed SystemHSZ · Traditional | Sodem Diffusion SA | 10/16/1995SE |
| K944590 | Ethicon Drill Bit and Drill GuideHSZ · Traditional | ETHICON, Inc. | 05/11/1995SE |
| K934336 | SpinalplaneHSZ · Traditional | Synvasive Technology, Inc. | 03/10/1995SN |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| K942760 | Pneumatic Wire TensionerHSZ · Traditional | Smith & Nephew Richards, Inc. | 09/06/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940109 | Tava K-WireHTY · Traditional | 02/22/1994SE |
| K885273 | Micro Surgical Instrument SystemHSZ · Traditional | 01/30/1989SE |
| K884492 | Micro Surgical Instrument SystemHSZ · Traditional | 11/16/1988SE |
| K872475 | Surgical BurGFF · Traditional | 07/02/1987SE |
| K863788 | SawbladeGFA · Traditional | 10/14/1986SE |
| K854543 | Pulse LavageFQH · Traditional | 01/27/1986SE |
Questions and answers
When was Tava Wire-Driver cleared by the FDA?
Tava Wire-Driver (K935367) received a 510(k) decision of Substantially Equivalent on April 21, 1994, 168 days after the submission was received.
What is the product code of K935367?
The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.